An Investigator And Subject Blinded, Sponsor Open, Randomized, Placebo Controlled, Multiple Dose Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of Pf-05089771 In Healthy Subjects And In Subjects With Osteoarthritis Of The Knee

Further study details as provided by Pfizer:

Primary Outcome Measures:

Number of participants with adverse events as a measure of safety and tolerability of PF-05089771 [ Time Frame: Days 1-16 ] [ Designated as safety issue: Yes ]

Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL) [ Time Frame: Days 1, 4 and 14 ] [ Designated as safety issue: No ]

Tmax = Time of maximum concentration of PF-05089771 in plasma (hr) [ Time Frame: Days 1, 6 and 14 ] [ Designated as safety issue: No ]

AUCtau= Area under the curve from the time of dosing to the next dose (ng.hr/mL) [ Time Frame: Days 1, 6 and 14 ] [ Designated as safety issue: No ]

Elimination half life (hr) = rate of elimination of PF-05089771 after the final dose [ Time Frame: day 14 PK samples collected only for 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL) [ Time Frame: Days 14, over 48 hours of PK samples collection ] [ Designated as safety issue: No ]

Daily pain score throughout the treatment period using an 11-point Numeric Rating Scale (NRS). [ Time Frame: Days 14, every day over 24 hours ] [ Designated as safety issue: No ]

Daily time to ascend and descend stairs. [ Time Frame: Days 14, every day over 24 hours ] [ Designated as safety issue: No ]

Daily pain following stair climbing and descending [ Time Frame: Days 14, every day over 24 hours ] [ Designated as safety issue: No ]

Daily time for self paced walk [ Time Frame: Days 14, every day over 24 hours ] [ Designated as safety issue: No ]

Daily pain following self paced walk. [ Time Frame: Days 14, every day over 24 hours ] [ Designated as safety issue: No ]

Treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.

12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.

Use of prescription or non-prescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.

As an exception, acetaminophen/paracetamol may be used at doses of ≤1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.

Blood donation of approximately 1 pint (500 mL) or more within 56 days prior to dosing.

History of sensitivity to heparin or heparin-induced thrombocytopenia.

Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.

Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Symptomatic OA of the hip ipsilateral to index knee which the patient considers more painful than the knee. History of diseases other than OA that may involve the index knee in the last 12 months prior to screening, including but not limited to: inflammatory joint diseases (i.e rehumatoid arthritis and gout), calcium crystal diseases, bursitis, tendinitis, tumors and cysts, ligament injuries, bone fractures, post-infective pathologies; widespread chronic pain conditions (ie, fibromyalgia) and neuropathic disorders.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529671